FDA Device recall Z-0011-2017

Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the b…

FDA Device
Class II
terminated
Published 2016-10-12

On 2016-10-12 the FDA classified a Class II recall of Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the b… by Philips Medical Systems, citing the infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0011-2017
Classification	Class II
Status	terminated
Initiated	2016-08-24
Published	2016-10-12
Last updated	2026-09-13 11:54 UTC
Company	Philips Medical Systems
Distribution	US

Product

Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Reason

The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.

Identifiers

code_info	30016, 30023, 30024, 30151, 32000, 32001, 32008, 32010, 32012, 32013, 32015, 32016, 32018, 32021, 32022, 32024, 32026,… 30016, 30023, 30024, 30151, 32000, 32001, 32008, 32010, 32012, 32013, 32015, 32016, 32018, 32021, 32022, 32024, 32026, 32028, 32032, 32033, 32034, 32036, 32037, 32041, 32042, 32043, 32044, 32046, 32047, 32048, 32049, 32050, 32051, 32052, 32053, 32054, 32055, 32056, 32057, 32058, 32059, 32060, 32061, 32062, 32063, 32064, 32065, 32066, 32067, 32068, 32069, 32070, 32071, 32072, 32073, 32074, 32075, 32076, 32077, 32078, 32079, 32080, 32081, 32082, 32084, 32085, 32086, 32087, 32088, 32089, 32090, 32091, 32092, 32093, 32094, 32095, 32096, 32097, 32098, 32099, 32100, 32101, 32102, 32103, 32104, 32105, 32106, 32108, 32109, 32110, 32111, 32112, 32113, 32114, 32115, 32116, 32117, 32118, 32119, 32120, 32121, 32122, 32123, 32124, 32125, 32126, 32127, 32128, 32129, 32130, 32131, 32133, 32134, 32135, 32136, 32137, 32138, 32139, 32140, 32141, 32142, 32143,

code_info

30016, 30023, 30024, 30151, 32000, 32001, 32008, 32010, 32012, 32013, 32015, 32016, 32018, 32021, 32022, 32024, 32026,…

30016, 30023, 30024, 30151, 32000, 32001, 32008, 32010, 32012, 32013, 32015, 32016, 32018, 32021, 32022, 32024, 32026, 32028, 32032, 32033, 32034, 32036, 32037, 32041, 32042, 32043, 32044, 32046, 32047, 32048, 32049, 32050, 32051, 32052, 32053, 32054, 32055, 32056, 32057, 32058, 32059, 32060, 32061, 32062, 32063, 32064, 32065, 32066, 32067, 32068, 32069, 32070, 32071, 32072, 32073, 32074, 32075, 32076, 32077, 32078, 32079, 32080, 32081, 32082, 32084, 32085, 32086, 32087, 32088, 32089, 32090, 32091, 32092, 32093, 32094, 32095, 32096, 32097, 32098, 32099, 32100, 32101, 32102, 32103, 32104, 32105, 32106, 32108, 32109, 32110, 32111, 32112, 32113, 32114, 32115, 32116, 32117, 32118, 32119, 32120, 32121, 32122, 32123, 32124, 32125, 32126, 32127, 32128, 32129, 32130, 32131, 32133, 32134, 32135, 32136, 32137, 32138, 32139, 32140, 32141, 32142, 32143,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0011-2017%22

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